SONIDEGIB PHOSPHATE - Generic Drug Details
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What are the generic drug sources for sonidegib phosphate and what is the scope of patent protection?
Sonidegib phosphate
is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sonidegib phosphate has one hundred and eighteen patent family members in forty-nine countries.
There is one drug master file entry for sonidegib phosphate. One supplier is listed for this compound.
Summary for SONIDEGIB PHOSPHATE
| International Patents: | 118 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 2 |
| Patent Applications: | 72 |
| DailyMed Link: | SONIDEGIB PHOSPHATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SONIDEGIB PHOSPHATE
Generic Entry Date for SONIDEGIB PHOSPHATE*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for SONIDEGIB PHOSPHATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Senhwa Biosciences, Inc. | Phase 1 |
| National Cancer Institute (NCI) | Phase 2 |
| Anne Chang | Phase 2 |
Pharmacology for SONIDEGIB PHOSPHATE
| Drug Class | Hedgehog Pathway Inhibitor |
| Mechanism of Action | Smoothened Receptor Antagonists |
US Patents and Regulatory Information for SONIDEGIB PHOSPHATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Sun Pharm | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Sun Pharm | ODOMZO | sonidegib phosphate | CAPSULE;ORAL | 205266-001 | Jul 24, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SONIDEGIB PHOSPHATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20120015363 | SALTS OF N-[6-CIS-2,6-DIMETHYLMORPHOLIN-4-YL)PYRIDINE-3-YL]-2-METHYL-4'-(TRIFLUOROMETHOXY)[1,1'-BIPHENYL]-3-CARBOXAMIDE | ⤷ Try a Trial |
| Costa Rica | 20110126 | SALES DE N-[6-(CIS-2,6-DIMETIL-MORFOLIN-4-IL) -PIRIDIN-3-IL] -2-METIL-4'-(TRIFLUORO-METOXI)-[1,1'-BIFENIL]-3-CARBOXAMIDA | ⤷ Try a Trial |
| Chile | 2011000551 | Sal difosfato de n-[6-(cis-2,6-dimetil morfolin-4-il)-piridin-3-il]-2-metil-4'-(trifluoro metoxi)-[1,1'-bifenil]-3-carboxamida; composicion farmaceutica,y su uso para tratar enfermedades que respondan a la modulacion de la actividad de la senda de señalizacion de hedgehog, tales como carcinoma y leucemia. | ⤷ Try a Trial |
| Brazil | PI0918629 | sal de n-[6-cis-2,6-dimetilmorfolin-4-il]piridina-3-il]-2-metil-4'-(trifluormetóxi)[1-1'-bifenil]-3-carboxcamida e composição farmacêutica | ⤷ Try a Trial |
| South Korea | 20080108343 | COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS | ⤷ Try a Trial |
| Norway | 20171395 | Forbindelser og sammensetninger som pinnsvin reaksjonsvei modulatorer | ⤷ Try a Trial |
| Mexico | 2008014190 | COMPUESTOS Y COMPOSICIONES COMO MODULADORES DE LA SENDA DE HEDGEHOG. (COMPOUNDS AND COMPOSITIONS AS HEDGEHOG PATHWAY MODULATORS.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SONIDEGIB PHOSPHATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2021328 | C02021328/01 | Switzerland | ⤷ Try a Trial | VERTRETERLOESCHUNG |
| 2021328 | 15C0077 | France | ⤷ Try a Trial | PRODUCT NAME: SONIDEGIB OU SEL,HYDRATE,OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
| 2021328 | 300790 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| 2021328 | PA2015051,C2021328 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SONIDEGIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, HIDRATAS ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/15/1030 20150818 |
| 2021328 | 1590062-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SONIDEGIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/15/1030 20150818 |
| 2021328 | 64/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: SONIDEGIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/15/1030 (MITTEILUNG) 20150818 |
| 2021328 | 2015C/059 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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